THRUWAYRecalls & reported problems across all models

We found 5 models of THRUWAY by Lake Region Medical in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2020 and Sep 24, 2026 — classified as 15 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (35 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported THRUWAY problems

THRUWAY models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• THRUWAY™ M001492971

  Wire, Guide, Catheter
  45 reports
• THRUWAY™ M001492981

  Wire, Guide, Catheter
  9 reports
• THRUWAY™ M001492791

  Wire, Guide, Catheter
  2 reports
• THRUWAY™ M001492831

  Wire, Guide, Catheter
  2 reports
• THRUWAY™ M001492921

  Wire, Guide, Catheter
  1 report

Recent THRUWAY adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Break

  During a reported complex atherectomy procedure involving a severely calcified, moderately tortuous distal superficial femoral artery (SFA) lesion with 100% stenosis, the physician advanced the Jetstream atherectomy too far, resulting in fracture and detachment of the distal tip of the guidewire, with the fractured segment remaining within the patient. An attempt was made to retrieve the detached wire tip using a snare; however, retrieval was unsuccessful. As stent implantation was already planned, the detached wire fragment was secured against the vessel wall with the implanted stent. No additional actions were taken. No patient effects were reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50883381 ↗
• MalfunctionAug 14, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253325 ↗
• InjuryAug 12, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50227841 ↗
• MalfunctionFeb 27, 2026Break

  EVENT DESCRIPTION: PER MEDWATCH, IT WAS REPORTED THAT: GUIDE WIRE BROKE OFF INSIDE A PATIENT DURING AN ENDOVASCULAR PROCEDURE. ADDITIONAL INFORMATION RECEIVED 27FEB2026: QUESTION: WAS THE DEVICE PRE-INSPECTED FOR KINKS, DAMAGE, OR IRREGULARITIES PRIOR TO USE? ANSWER: YES. QUESTION: WAS THERE ANY DAMAGE NOTED PRIOR TO USE? ANSWER: NO. QUESTION:WHAT SPECIFIC ENDOVASCULAR PROCEDURE WAS BEING PERFORMED? ANSWER:ANGIOGRAM WITH INTERVENTION QUESTION:WHAT WAS THE ACCESS SITE? ANSWER:FEMORAL ACCESS. QUESTION:WHAT DEVICES WERE USED IN CONJUNCTION WITH THE GUIDEWIRE (PLEASE LIST ALL DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.)? ANSWER: JETSTREAM ROTATIONAL ATHERECTOMY (2.4 MM) BALLOON ANGIOPLASTY 5 X 100 MM STERLING BALLOON 6 X 100 MM ELUVIA STENT BALLOON ANGIOPLASTY 4 X 100 MM STERLING BALLOON DRUG-COATED BALLOON ANGIOPLASTY 5 X 100 MM RANGER BALLOON FOR 3-MINUTE DURATION QUESTION:WERE THERE MULTIPLE DEVICE EXCHANGES OVER THE WIRE? ANSWER: YES (SEE ABOVE) QUESTION:WAS THE WIRE USED TO CROSS A DIFFICULT OR CALCIFIED LESION? ANSWER: NO QUESTION:WAS THE LESION HEAVILY CALCIFIED? ANSWER: YES QUESTION:DID THE END USER ENCOUNTER ANY RESISTANCE CROSSING THE LESION?

  Patient problems: Foreign Body In Patient

  MAUDE report 24475467 ↗
• MalfunctionFeb 5, 2026Break

  EVENT DESCRIPTION: WHEN THE TECHNICIAN REMOVED THE WIRE, HE NOTICED THAT IT HAD A SLIGHT DEFORMATION, REQUIRING ANOTHER WIRE. SUPPLEMENTAL INFORMATION INDICATED THAT THE DEFORMATION WAS FIRST NOTICED AFTER THE DISPENSER ASSEMBLY HAD BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272856 ↗
• MalfunctionJan 7, 2026Entrapment of Device

  ADDITIONAL INFORMATION PROVIDED: QUESTION: PLEASE LIST ALL OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.? ANSWER: ONLY JETSTREAM WAS USED DURING THE PROCEDURE. QUESTION: WAS THERE ANY RESISTANCE FELT DURING INSERTION OR ADVANCEMENT OF THE WIRE TO TREATMENT SITE? ANSWER: YES. QUESTION: WERE THERE ANY PATIENT COMPLICATIONS DURING OR AFTER THE PROCEDURE THAT WERE RELATED TO THE PRODUCT ISSUE? ANSWER: NO. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED ISSUE? ANSWER: THE END USER BELIEVES IT IS A QUALITY ISSUE OF THE DEVICE. QUESTION: HOW WAS THE PROCEDURE COMPLETED? ANSWER: THE PROCEDURE WAS COMPLETED AFTER THE CATHETER WAS WITHDRAWN FOLLOWING ROTATIONAL CUTTING AND THEN DILATED WITH A BALLOON. QUESTION: WAS FLUOROSCOPY IN USE DURING THE PROCEDURE? ANSWER: YES. QUESTION: WAS THERE ANY DAMAGE NOTED TO THE WIRE PRIOR TO OR AFTER USE? IF SO, PLEASE DESCRIBE. ANSWER: NO. QUESTION: WAS TYPE OF DAMAGE WAS NOTED ON THE CATHETER AFTER USE, AND WAS THIS A CONTRIBUTING FACTOR TO THE ENTRAPMENT BETWEEN THE TWO DEVICES? PLEASE DESCRIBE. ANSWER: AFTER USING THE CATHETER, IT WAS DISCOVERED THAT THE CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991735 ↗
• InjuryDec 22, 2025Break; Break

  DESCRIBE THE EVENT OR PROBLEM: WHEN ATTEMPTING TO REMOVE PIONEER RE-ENTRY DEVICE THE VERY TIP OF THE THRUWAY WIRE SHEARED OFF AND REMAINED IN THE DISSECTED PLAIN OF THE SFA [SUPERFICIAL FEMORAL ARTERY]. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ANGIOGRAM. WHAT PROBLEM DID THE USER HAVE: OTHER.

  Patient problems: Insufficient Information

  MAUDE report 23865552 ↗
• MalfunctionDec 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT: IT WAS STUCK WITH THE THRUWAY. PROCEDURE COMPLETED USING A DIFFERENT DEVICE (SAME MODEL) PATIENT OUTCOME: NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779844 ↗
• MalfunctionDec 3, 2025Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION PROVIDED: QUESTION: THE EVENT DESCRIPTION STATES, AFTER THE THRUWAY GUIDEWIRE WAS UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE AND THE TIP OF THE ROTARY CUTTING CATHETER WERE STUCK DURING THE ROTARY CUTTING PROCESS. WHAT IS MEANT BY AFTER THE THRUWAY GUIDEWIRE WAS UNPACKING? ANSWER: AFTER UNPACKING THE PACKAGE, THE PHYSICIAN INSERTED THE GUIDEWIRE INTO THE LESION. QUESTION: PLEASE LIST ALL OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. ANSWER: ONLY THE VASCULAR PLAQUE RESECTION CONTROL DEVICE WAS USED. QUESTION: WAS THERE ANY RESISTANCE FELT DURING INSERTION OR ADVANCEMENT OF THE WIRE OR CATHETER TO TREATMENT SITE? ANSWER: NO. QUESTION:PLEASE CLARIFY, WERE BOTH THE CATHETER AND WIRE REMOVED AS ONE UNIT? ANSWER: YES. QUESTION: HOW WAS THE WIRE REMOVED FROM THE PATIENT? ANSWER: THE CATHETER AND WIRE WERE REMOVED AS ONE UNIT. QUESTION:WAS THE SAME CATHETER USED TO COMPLETE THE PROCEDURE? ANSWER: REPLACED A NEW CATHETER TO COMPLETE THE PROCEDURE. QUESTION:WERE THERE ANY PATIENT COMPLICATIONS DURING THE PROCEDURE? ANSWER: NO. QUESTION:WHAT DOES THE END USER BELIEVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED ISSUE? ANSWER: THE PHYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709197 ↗
• InjuryJul 8, 2025Break; Break

  ADDITIONAL INFORMATION: QUESTION: LISTING OF THE MODEL OF ALL DEVICES USED IN THE PROCEDURE, INCLUDE THE MODEL, BRAND NAMES, SIZES ETC.? ANSWER: JETSTREAM2.4/3.4MM QUESTION: WHAT OTHER DEVICE(S) WERE BEING USED AT THE TIME THE DETACHMENT OCCURRED? ANSWER: JETSTREAM2.4/3.4MM QUESTION: WHEN DURING THE PROCEDURE DID THE DETACHMENT OCCUR? ANSWER: AFTER CUTTING, THE JETSTREAM WAS REMOVED AND FLUOROSCOPY WAS PERFORMED. QUESTION: WAS RESISTANCE NOTED PRIOR TO THE DETACHMENT OR AT ANY TIME DURING INSERTION, ADVANCING, OR WITHDRAWING THE WIRE? ANSWER: UNKNOWN. QUESTION: WAS GUIDEWIRE MOVEMENT EXAMINED UNDER FLUOROSCOPY THROUGHOUT THE PROCEDURE TO MONITOR THE THRUWAY GUIDEWIRE? ANSWER: YES. QUESTION: WAS TORQUE APPLIED TO THE GUIDEWIRE UNDER RESISTANCE AT ANY TIME DURING THE PROCEDURE? ANSWER: UNKNOWN. QUESTION: WHAT DOES THE END USER/PHYSICIAN BELIEVE CAUSED THE WIRE DETACHMENT? ANSWER: IN THE ANGIO TEST, THE TIP OF THE PRODUCT WAS CRUMPLED AND BROKEN, SO IT BECAME STUCK SOMEWHERE IN THE BLOOD VESSEL, AND IT MAY HAVE BROKEN OFF WHEN THE PRODUCT WAS PULLED OUT. QUESTION: BEYOND THE WIRE BEING SNARED, WAS THERE ANY PATIENT COMPLICATION DUE TO THE DETACHMENT? ANSWER: NO. QUESTION: WAS THERE AN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22440076 ↗
• InjuryJun 25, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: AFTER OPENING THE BLOOD VESSEL, THE 0.018 INCH GUIDEWIRE WAS REPLACED WITH THE THRUWAY GUIDEWIRE. THE TIP OF THE GUIDEWIRE CROSSED THE LESION AND REACHED THE DISTAL LANDING AREA. THEN THE JESTREAM CATHETER WAS ASSEMBLED ACCORDING TO THE IFU AND DELIVERED INTO THE BODY ALONG THE THRUWAY GUIDEWIRE AFTER COMPLETING THE PRIMING OUTSIDE THE PATIENT. THE JESTREAM (HEREINAFTER REFERRED TO AS JS) DEVICE WAS STARTED IN BLADE DOWN MODE FOR PROCEDURE, AND THE JS CATHETER WAS SLOWLY PUSHED TO CUT THE PLAQUE ACCORDING TO THE IFU. WHEN THE CATHETER WAS PUSHED FOR ABOUT 5MM, THE JS CATHETER SOUND WAS ABNORMAL, AFFECTED THE GUIDEWIRE ROTATED ALONG WITH THE CATHETER. THE PHYSICIAN STOPPED THE OPERATION AND WITHDREW THE CATHETER. IT WAS FOUND THAT THE CATHETER AND THE GUIDEWIRE HAD BECOME LOCKED TOGETHER AND COULD NOT BE SEPARATED. THE PHYSICIAN REPLACED THE NEW GUIDEWIRE AND JS CATHETER TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 22326794 ↗
• MalfunctionJun 18, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: AFTER INSERTING THE THRUWAY, SENTINAL DELIVERY WAS PERFORMED, BUT THE WIRE GOT KINKED AND THE DEVICE GOT STUCK. THE WIRE WAS REMOVED OUTSIDE THE BODY TOGETHER WITH THE DEVICE. SINCE THE WIRE COULD BE PULLED OUT OF THE DEVICE OUTSIDE THE BODY, A DIFFERENT DEVICE (DIFFERENT MODEL) WAS USED, AND THE PROCEDURE WAS COMPLETED. SHAPING: NO. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287097 ↗
• MalfunctionJun 18, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: IT EITHER KINKED OR GOT STUCK DURING USE IN COMBINATION WITH THE JETSTREAM. SHAPING: NO PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY INTRODUCER SHEATH USED: YES, ABLE TO USE THE DEVICE, DESTINATION 7FR. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 16JUN2025: QUESTION: WHAT WAS THE ISSUE NOTED WITH THE THRUWAY? RESPONSE: WHEN USED IN CONJUNCTION WITH JETSTREAM, THE THRUWAY BECOME STUCK BECAUSE IT MAY HAVE KINKED. QUESTION: WAS THE THRUWAY WIRE KINKED? IF SO, WHERE WAS THE KINK LOCATED? RESPONSE: UNKNOWN, THE THRUWAY MAY HAVE KINKED QUESTION: WAS THE THRUWAY WIRE STUCK WITH THE JETSTREAM DEVICE? RESPONSE: YES QUESTION: WERE THE THRUWAY AND THE JETSTREAM DEVICES REMOVED FROM THE PATIENT AS ONE UNIT OR WHERE THEY REMOVED SEPARATELY FROM THE PATIENT? RESPONSE: THE THRUWAY AND THE JETSTREAM DEVICES WERE REMOVED FROM THE PATIENT AS ONE UNIT QUESTION: PLEASE CLARIFY WHAT DEVICES WERE USED TO COMPLETE THE PROCEDURE (A NEW THRUWAY WIRE AND A NEW JETSTREAM DEVICE, A NEW THRUWAY WIRE AND THE ORIGINAL JETSTREAM DEVICE, A NEW JETSTREAM DEVICE AND THE ORIGINAL THRUWAY WIRE) RESPONSE: REPLACED WITH A NEW THRUWAY AND A NEW JETSTREAM (UPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283940 ↗
• InjuryMar 17, 2025Break; Break

  EVENT DESCRIPTION: PROCEDURE WAS A LE ANGIO. 7FR DESTINATION SHEATH UP AND OVER. .014 X 300CM THRUWAY WIRE CROSSED INTO THE RT PERONEAL. BALLOONED THE RT. PERONEAL WITH 2.5X 200 ARMADA BALLOON. JETSTREAM (JS) 2.1/3.0 OF THE RT. SFA INTO PROXIMAL POPLITEAL WAS SUCCESSFUL. WHEN 'WALKING OUT' THE JS OVER THE .014 THRUWAY THE WIRE KINKED (OUTSIDE OF THE BODY). WIRE ACCESS WAS LOST. UPON REWIRING THE VESSEL WITH A .035 STIFF GLIDE WIRE, A 1CM-2CM WIRE TIP WAS NOTED IN THE MID PERONEAL. WE LOOKED AT THE THRUWAY WIRE THAT WAS REMOVED AND THE TIP APPEARED TO BE MISSING. THE DR. PASSED A BERN CATHETER PAST THE WIRE TIP. THE WIRE TIP DID NOT MOVE. A SECOND .014 THRUWAY WIRE CROSSED INTO THE RT. PERONEAL. THE SAME 2.5 X 200 ARMADA WAS INTRODUCED PAST THE BROKEN WIRE TIP AND INFLATED. AGAIN, THE WIRE TIP DID NOT APPEAR TO MOVE. IT WAS THEN NOTED THE WIRE TIP MIGHT BE IN A COLLATERAL. SEVERAL IMAGES WERE TAKEN. PATIENT HAD BRISK FLOW TO THE FOOT. THE CASE ENDED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: OTHER. PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: TIP OF WIRE BROKE OFF. LEFT IN PATIENTS LEFT PERONEAL (OR COLLATERAL BRANCH). IN THE PHYSICIAN'S OPINION, DID THE DEV

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21618883 ↗
• InjuryJan 23, 2025Break; Break

  EVENT DESCRIPTION: TRIED TO ADVANCE AND DEPLOY STENT AND WIRE BECAME WRAPPED AND BROKE OFF WITH PART OF THE STENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? SNARED OUT THE PIECES. WHAT IS THE NEXT COURSE OF ACTION?: UNKNOWN. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: OTHER. PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: SNARE NEEDED. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN. MEDICAL OR SURGICAL INTERVENTIONS: SNARED OUT PIECE OF STENT AND WIRE PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. QUESTION: HOW WAS THE DEVICE REMOVED FROM THE PATIENT (I.E. PULLED, SNARED, ETC)? ANSWER: SNARED. QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT IN ONE PIECE? ANSWER: UNKNOWN. PHOTO OR VIDEO OF ISSUE: NO. PROCUDURE WAS COMPLETED USING AN ALTERNATIVE METHOD/DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21217014 ↗

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